Selinexor Combination Therapy for Multiple Myeloma

Recruiting at 1 trial location

Overseen By Kristin Ivanovski

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Hackensack Meridian Health

Must be taking: Carfilzomib, Pomalidomide, Daratumumab

Must not be taking: Glucocorticoids

Disqualifiers: Smoldering MM, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: Up to 30 months

96 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a prospective, 2-arm (with an additional exploratory arm), open-label, multicenter study looking at the response rate of patients receiving selinexor (KPT-330), in combination with carfilzomib, daratumumab or pomalidomide. Multiple Myeloma patients with documented disease progression or refractory disease while on current treatment with any carfilzomib-containing regimen (arm 1), any pomalidomide-containing regimen (arm 2) or any daratumumab-containing regimen (exploratory arm) will be included in the study. Patients will be assigned to the respective groups according to their current treatment. If a subject has received more than one of the above therapies, then assignment will be made at their physician's discretion (e.g treatment decision can be made based upon patient and physician preferred tolerance.). Patients will receive treatment until progressive disease (PD), death, toxicity that cannot be managed by standard of care, or withdrawal, whichever occurs first.

Research Team

Noa Biran, MD

Principal Investigator

Hackensack Meridian Health

Eligibility Criteria

Adults with Multiple Myeloma showing disease progression on current treatments including carfilzomib, pomalidomide, or daratumumab can join. They must have good organ function and be able to follow the study's procedures. Pregnant women, those with serious health issues that could affect participation, recent recipients of certain therapies, or individuals with active infections cannot participate.

Inclusion Criteria

I am using effective birth control methods.

My kidney function is good as tested within the last 28 days.

Compliance with transfusion intervals and guidelines

Exclusion Criteria

You are not expected to live for more than 3 months.

I am unable or unwilling to take recommended supportive medications.

I do not have an active infection needing IV drugs within the last week.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive selinexor in combination with carfilzomib, daratumumab, or pomalidomide on a 28-day cycle until progressive disease, death, toxicity, or withdrawal

Up to 30 months

Visits on days 1, 8, 15, and 22 of each cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

Treatment Details

Interventions

• Carfilzomib
• Daratumumab
• Pomalidomide
• Selinexor

Trial Overview The trial is testing Selinexor in combination with either Carfilzomib, Daratumumab or Pomalidomide in patients whose Multiple Myeloma has worsened despite treatment. It aims to see how well patients respond to this mix of drugs until they experience disease progression or unacceptable side effects.

Participant Groups

Group I: Pomalidomide-containing Regimen Experimental Treatment 3 Interventions

Pomalidomide 4 mg po daily for 21 days. Dexamethasone 20 mg if ≥ 75 years old and 40 mg if \< 75 years old on days 1, 8, 15 and 22. Selinexor 60 mg on days 1, 8 and 15.

Group II: Exploratory/Daratumumab-containing Regimen Experimental Treatment 3 Interventions

Daratumumab on current schedule (16 mg/kg IV days 1, 8, 15 and 22 for cycles 1-2; days 1 and 15 for cycles 3-6; day 1 for cycle 7 and on). Dexamethasone 20 mg if ≥ 75 years old and 40 mg if \< 75 years old on days 1, 8, 15 and 22. Selinexor 100 mg on days 1, 8, 15 and 22.

Group III: Carfilzomib-containing Regimen Experimental Treatment 3 Interventions

Carfilzomib 56 mg/m2 on days 1, 8 and 15. Dexamethasone 20 mg if ≥ 75 years old and 40 mg if \< 75 years old on days 1, 8, 15 and 22. Selinexor 80 mg on days 1, 8 and 15.

Carfilzomib is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Kyprolis for:

• Multiple myeloma

Approved in European Union as Kyprolis for:

• Multiple myeloma

Approved in Canada as Kyprolis for:

• Multiple myeloma

Approved in Japan as Kyprolis for:

• Multiple myeloma

Who Is Running the Clinical Trial?

Hackensack Meridian Health

Lead Sponsor

Trials

141

Recruited

42,900+

Karyopharm Therapeutics Inc

Industry Sponsor

Trials

89

Recruited

7,200+

Richard Paulson

Karyopharm Therapeutics Inc

Chief Executive Officer since 2021

MBA from the University of Toronto's Rotman School of Management

Reshma Rangwala

Karyopharm Therapeutics Inc

Chief Medical Officer since 2023

MD, PhD